MindRhythm

# High-Level Overview

MindRhythm is a medical technology company developing noninvasive diagnostic devices to prevent neurological injuries, primarily strokes and concussions.[1][3] Founded in 2018 and based in San Francisco, the company has raised $5 million in seed funding and focuses on solving a critical clinical problem: the inability to rapidly and objectively distinguish between stroke types in prehospital settings.[1][2]

The company serves the healthcare industry—including emergency medical services (EMS), hospitals, operating rooms, and athletic settings—by providing real-time visibility into life-threatening neurological situations.[3] MindRhythm's core mission is to reduce time to treatment for Large Vessel Occlusion (LVO) strokes, the most debilitating stroke type, through intelligent patient triage and monitoring technology that enables clinicians to intervene before brain damage occurs.[2]

# Origin Story

MindRhythm was founded in 2018 by world-renowned scientific experts with significant commercialization experience.[1] The company's origin is deeply personal: co-founder Paul discovered the "Headpulse algorithm" following the death of his wife due to stroke, driving his determination to prevent similar tragedies by enabling accurate, noninvasive stroke diagnosis.[4]

The founding team combines clinical expertise with commercial acumen. John Keane, Co-Founder and CEO, brings three decades of medical device experience and has been involved in more than 30 product launches focused on neurological disorders.[4] Wade Smith, MD, PhD, Co-Founder and Chair of the Scientific Advisory Board, is a neurocritical care physician and Chief of the Neurovascular Division at UCSF who designed device prototypes and co-developed the artificial intelligence algorithms underlying MindRhythm's technology.[4] This blend of clinical innovation and market expertise positioned the company to address a known gap: as Keane notes, "MindRhythm differentiates itself from anything else on the market. It provides a solution for a known problem, where nothing currently exists."[4]

# Core Differentiators

• Proprietary biomarker technology: MindRhythm developed a novel, noninvasive diagnostic device that produces a unique biomarker with multiple clinical applications, specifically designed to detect Large Vessel Occlusion strokes and monitor concussion recovery.[3]

• FDA recognition: The company received a Breakthrough Device Designation from the FDA based on data from the EPISODE-PS-COVID study, validating the clinical significance of its approach.[1]

• Integrated communication platform: Beyond detection, MindRhythm's technology includes a proprietary communication strategy that triages patients, communicates patient data, and provides remote location status to hospital teams prior to arrival—optimizing treatment decisions and outcomes.[2]

• Multi-application scope: While initially focused on stroke triage, the technology is being tested for concussion monitoring and recovery determination, as well as prevention of primary and secondary injury across various neurological conditions.[3]

• Clinical leadership: The scientific advisory board includes leading neurocritical care physicians with expertise in stroke management, clinical trial design, and FDA pathways, ensuring clinical credibility and regulatory alignment.[4]

# Role in the Broader Tech Landscape

MindRhythm operates at the intersection of two significant healthcare trends: the digitization of diagnostics and the push to reduce time-to-treatment in acute care settings. Stroke remains the 5th leading cause of death, with approximately 800,000 strokes occurring annually in the United States, yet the lack of objective prehospital diagnosis means many patients are transported to the wrong facility type, delaying critical intervention.[2]

The company's approach mirrors successful models in cardiology—specifically the STEMI (ST-elevation myocardial infarction) protocol—which systematized rapid diagnosis and treatment routing to save lives at scale.[2] By applying similar logic to stroke, MindRhythm addresses a market gap where no objective diagnostic tool currently exists in the prehospital setting. This timing is critical: as healthcare systems increasingly invest in stroke centers and thrombectomy capabilities, the ability to identify LVO patients early and route them appropriately becomes a high-value capability.

The broader medtech ecosystem is moving toward portable, AI-enabled diagnostics that reduce clinical variability and improve outcomes. MindRhythm's noninvasive, disposable device fits this trend while addressing a life-or-death clinical need with clear economic incentives for healthcare systems.

# Quick Take & Future Outlook

MindRhythm is at an inflection point. With FDA Breakthrough Device Designation and early clinical validation, the company is positioned to move toward commercialization and broader market adoption. The next critical milestones will be completing the pivotal EPISODE study and securing FDA clearance, which would unlock deployment across EMS networks and hospitals nationwide.

The company's expansion beyond stroke into concussion monitoring and other neurological conditions suggests a longer-term vision of becoming a platform for neurological injury prevention and management. As awareness of concussion's role as a risk factor for stroke, CTE, Alzheimer's, and depression grows, demand for objective monitoring tools will likely increase.

The key question ahead: Can MindRhythm achieve the adoption and integration into EMS workflows that the STEMI protocol achieved for cardiology? Success would position the company as a foundational tool in acute neurological care, with significant commercial and clinical impact. The combination of clinical leadership, regulatory momentum, and a clear, unmet market need suggests the company has the ingredients to scale—if execution matches the vision.